# FDA 483 - HTO Nevada Inc - August 22, 2025

Source: https://www.keypedia.com/records/483/hto-nevada-inc/bed8f068-8fa7-45a5-bea9-4ae8830ea059

> FDA 483 for HTO Nevada Inc on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HTO Nevada Inc
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: HTO Nevada Inc. dba Kirkman, a contract drug manufacturer in Lake Oswego, OR, received a Form 483 with eight observations, many of which were repeats. The inspection revealed significant deficiencies across quality control, production, stability testing, and labeling, including failures to investigate discrepancies, ensure contract lab GMP compliance, perform annual product reviews, and validate processes. These issues indicate a lack of adequate controls to ensure drug product identity, strength, purity, and quality.

## Related Documents

- [483 - 2025-08-22](https://www.keypedia.com/records/483/hto-nevada-inc/489eb225-eee5-499e-9844-f959420f8584)

## Related Officers

- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Statistical Science Director](https://www.keypedia.com/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.keypedia.com/companies/hto-nevada-inc/c42bc0ec-4d68-4db5-8860-0f6c8e248c99

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913